510(k) · Cleared
ClearedThe ClearSight finger cuffs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 21, 2019 as substantially equivalent to K160552 (Edwards Lifesciences, LLC, 2016) and 1 other predicate after a 144-day review. Its family tree reaches back 11 generations to 2000. 1 of the 55 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Jun 21, 2019
- Review
- 144 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K000126 (2000). 25 ancestors in all, the oldest K822055 (1982). 29 later devices descend from it, 3 citing it directly. 1 of the 55 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 7 generations between
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK190130 The ClearSight finger cuffsEdwards Lifesciences, LLC · 2019
- Descendant · cites it directly · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 2 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
- Descendant · 2 generations on · 15 of its ownK211465 HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced…Edwards Lfesciences · 2021
- Descendant · 3 generations on · 14 of its ownK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
- Descendant · 4 generations on · 7 of its ownK223865 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2023
Show all 11 generations
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 10 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 9 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 8 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 7 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 6 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- 5 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 4 generations backK101123 Nexfin Model 2Bmeye B.V. · 2010
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK190130 The ClearSight finger cuffsEdwards Lifesciences, LLC · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…direct predicate · 2016
Most influential descendants
Showing 5 of 29 · See all- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · cites it directly27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 2 generations on18descendants
- K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences · 2021 · 2 generations on15descendants
- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC · 2022 · 3 generations on14descendants
- K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC · 2023 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −10 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −9 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −8 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −7 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −6 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| −5 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −4 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| −3 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| −2 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| −1 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| 0 (this device) | K190130 | The ClearSight finger cuffs | Edwards Lifesciences, LLC | 2019 | — |
| +1 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +2 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
| +2 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring… | Edwards Lfesciences | 2021 | — |
| +3 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2022 | — |
| +4 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted… | Edwards Lifesciences, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Summary page 4…assification Non-Invasive Blood Pressure Measurement Name (21 CFR 870.1130) Regulation Class / Class II Product Code DXN K160552 – ClearSight finger cuff included in the EV1000 Primary Predicate Clinical Platform™ NI and the ClearSight™… | 2016 |
| * | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemSummary page 4…Clinical Platform™ NI and the ClearSight™ Finger Cuff or Device ClearSight™ System (cleared June 1, 2016). Secondary K140312 – ClearSight finger cuff included in the EV1000 Predicate (for Clinical Platform™ NI and the ClearSight™ Fin… | 2014 |
What descends from it? (29)
See all 293 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201446 (Edwards Lifesiences, LLC, 2020) has gone furthest, with 27 descendants of its own.
- 8 other devices also cite its predicate K160552.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The ClearSight™ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the EV1000 Clinical Platform NI.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190130 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190130: The ClearSight finger cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026